MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	H7493926020270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: synergy ii us mr 2.75 x 20mm stent delivery system was returned for analysis.The hypotube of device was received however the distal part of the device including midshaft, inner &outer extrusion, balloon, stent and tip were not received.The distal portion of the device containing the stent was not returned for analysis and thus a review of the manufacturing crimp data for this device was performed.The review did not highlight any anomalies with the device.The maximum stent profile was within max crimped stent profile measurement.The hypotube and outer extrusion was broken at approximately 1170mm distal to the distal end of the strain relief.The distal portion of the device was not returned.Multiple hypotube kinks were noted.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 18-may-2018.This device was received with no reported issues.However, upon review of this device, hypotube was broken and the shaft polymer extrusion was detached.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7599079
• Report Number: 2134265-2018-05007
• Device Sequence Number: 19403690
• Product Code: NIQ
• UDI-Device Identifier: 08714729840169
• UDI-Public: 08714729840169
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2016
• Device Model Number: H7493926020270
• Device Catalogue Number: 39260-2027
• Device Lot Number: 18425795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1